[Federal Register Volume 64, Number 149 (Wednesday, August 4, 1999)]
[Rules and Regulations]
[Pages 42269-42275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19984]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 Prices of new books are listed in the first FEDERAL REGISTER issue of each 
 week.
 
 ========================================================================
 

  Federal Register / Vol. 64, No. 149 / Wednesday, August 4, 1999 / 
Rules and Regulations  

[[Page 42269]]


=======================================================================
-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION

10 CFR Part 31

RIN 3150--AG06


Requirements for Those Who Possess Certain Industrial Devices 
Containing Byproduct Material to Provide Requested Information

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations to add an explicit requirement that general licensees, who 
possess certain measuring, gauging, or controlling devices that contain 
byproduct material, provide the NRC with information concerning these 
devices. The NRC intends to use this provision to request information 
concerning devices that present a comparatively higher risk of exposure 
to the public or property damage. The final rule is intended to help 
ensure that devices containing byproduct material are maintained and 
transferred properly and are not inadvertently discarded.

EFFECTIVE DATE: October 4, 1999.

FOR FURTHER INFORMATION CONTACT: Catherine R. Mattsen, Office of 
Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, telephone (301) 415-6264, or e-
mail at [email protected]; or Jayne McCausland, Office of Nuclear Material 
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001, telephone (301) 415-6219, or e-mail at JMM[email protected].

SUPPLEMENTARY INFORMATION:

Background

    On February 12, 1959 (24 FR 1089), the Atomic Energy Commission 
(AEC) amended its regulations to provide a general license for the use 
of byproduct material contained in certain measuring, gauging, or 
controlling devices (10 CFR 30.21(c)). Under current regulations in 10 
CFR 31.5, certain persons may receive and use a device containing 
byproduct material under this general license if the device has been 
manufactured and distributed according to the specifications contained 
in a specific license issued by the NRC or by an Agreement State. A 
specific license authorizing distribution of generally licensed devices 
is issued if a regulatory authority determines that the safety features 
of the device and the instructions for safe operation of that device 
are adequate and meet regulatory requirements.
    The person or firm who receives such a device is a general 
licensee. The general licensee is subject to requirements for 
maintaining labels, following instructions for use, storing or 
disposing of the device properly, and reporting transfers and failure 
of or damage to the device. For some devices, the general licensee must 
also comply with leak testing requirements. The general licensee is 
also subject to the terms and conditions in 10 CFR 31.2 concerning 
general license requirements, transfer of byproduct material, reporting 
and recordkeeping, and inspection. The general licensee must comply 
with the safety instructions contained in or referenced on the label of 
the device and must have the testing or servicing of the device 
performed by an individual who is authorized to manufacture, install, 
or service these devices.
    A generally licensed device usually consists of radioactive 
material, contained in a sealed source, within a shielded device. The 
device is designed with inherent radiation safety features so that it 
can be used by persons with no radiation training or experience. Thus, 
the general license is meant to simplify the licensing process so that 
a case-by-case determination of the adequacy of the radiation training 
or experience of each user is not necessary.
    There are about 45,000 general licensees under 10 CFR 31.5. These 
licensees possess about 600,000 devices that contain byproduct 
material. The NRC has not contacted general licensees on a regular 
basis because of the relatively small radiation exposure risk posed by 
these devices and the very large number of general licensees. However, 
general licensees are not always aware of applicable regulations and 
thus are not necessarily complying with all of the applicable 
requirements. The NRC is particularly concerned about occurrences where 
generally licensed devices containing radioactive material have not 
been properly handled or properly disposed of. In some cases, this has 
resulted in radiation exposure to the public and contamination of 
property. Although known exposures generally have not exceeded the 
public dose limit, there is a potential for significant exposures. When 
a source is accidentally melted in a steel mill, considerable 
contamination of the mill, the steel product, and the wastes from the 
process, the slag and the baghouse dust, can result.
    The NRC conducted a 3-year sampling (1984 through 1986) of general 
licensees to assess the effectiveness of the general license program. 
The sampling revealed several areas of concern regarding the use of 
generally licensed devices. In particular, the NRC concluded that many 
general licensees are not aware of the appropriate regulations. Also, 
approximately 15 percent of all general licensees sampled could not 
account for all of their generally licensed devices. The NRC concluded 
that these problems could be remedied by more frequent and timely 
contact between the general licensee and the NRC.
    On December 27, 1991 (56 FR 67011), the NRC published a notice of 
proposed rulemaking concerning the accountability of generally licensed 
devices. The proposed rule contained a number of provisions, including 
a requirement for general licensees under 10 CFR 31.5 to provide 
information to the NRC upon request, through which a device registry 
could be developed. The proposed rule also included requirements in 10 
CFR 32.51a and 32.52 for the specific licensees who manufacture or 
initially transfer generally licensed devices. Although the public 
comments received were reviewed and a final rule developed, a final 
rule was not issued because the resources needed to implement the 
proposed rule properly were not available.
    The NRC continued to consider the issues related to the loss of 
control of generally licensed, as well as

[[Page 42270]]

specifically licensed, sources of radioactivity. In July 1995, the NRC, 
with assistance from the Organization of Agreement States, formed a 
working group to evaluate these issues. A final report was completed in 
July 1996 and published in October 1996 as NUREG-1551, ``Final Report 
of the NRC-Agreement State Working Group to Evaluate Control and 
Accountability of Licensed Devices.''
    In considering the recommendations of the working group, the NRC 
decided, among other things, to again initiate rulemaking to establish 
an annual registration program of devices generally licensed under 10 
CFR 31.5 that would be similar to the program originally proposed in 
the December 27, 1991, proposed rule. However, the NRC decided to do so 
only for those devices that present a higher risk, compared to other 
generally licensed devices, of potential exposure to the public and 
property loss if control of the device were lost. The NRC found the 
working group process valuable in identifying criteria for categorizing 
devices that are more likely to present a significant risk by exposure 
of the public or through contamination of property.
    On December 2, 1998 (63 FR 66492), the Commission again proposed 
the addition of an explicit requirement to provide information in 
response to requests made by the NRC. While the rule applies to all 10 
CFR 31.5 general licensees, the NRC plans to contact only those general 
licensees identified by the working group for the purpose of the 
registration program. For the most part, general licensees using 
devices meeting these criteria have a limited number of devices that 
will require registration.
    In that notice (at 63 FR 66493), the NRC also withdrew the December 
27, 1991, proposed rule. The NRC has reviewed the other provisions 
contained in the December 27, 1991, proposed rule and the 
recommendations of the working group and developed additional 
requirements in a separate proposed rule published July 26, 1999 (64 FR 
40295). The recommendations made in NUREG-1551 were considered in 
developing the separate, more comprehensive proposed rule issued July 
26, 1999. That proposed rule addresses fees for registration, 
additional reporting, recordkeeping, and labeling requirements for 10 
CFR 32.51 licensees, and compatibility of Agreement State regulations 
in this area.
    On March 9, 1999 (64 FR 11508), the Commission established an 
interim enforcement policy for violations of 10 CFR 31.5 that are 
discovered and reported by licensees during the initial cycle of the 
registration program. The initial cycle is considered to be the 
issuance of one round of registration requests to all affected general 
licensees. This policy supplements the normal NRC Enforcement Policy in 
NUREG-1600, Rev. 1. It will remain in effect through one complete cycle 
of the registration program.
    Under this interim enforcement policy, enforcement action normally 
will not be taken for violations of 10 CFR 31.5 that are identified by 
the general licensee, and reported to the NRC if reporting is required, 
provided that the general licensee--
    Takes appropriate corrective action to address the specific 
violations and prevent recurrence of similar problems; and
    Has undertaken good faith efforts to respond to NRC notices and 
provide requested information.
    This change from the Commission's normal enforcement policy is 
intended to remove the potential for the threat of enforcement action 
to be a disincentive for the licensee to identify deficiencies.
    Under the interim enforcement policy, enforcement action, including 
issuance of civil penalties and Orders, may be taken where there is --
    (1) Failure to take appropriate corrective action to prevent 
recurrence of similar violations;
    (2) Failure to respond and provide the information required by 
regulation;
    (3) Willful failure to provide complete and accurate information to 
the NRC; or
    (4) Other willful violations, such as willfully disposing of 
generally licensed material in an unauthorized manner.
    As noted in the December 2, 1998, proposed rule, and discussed 
further in the separate, more comprehensive proposed rule of July 26, 
1999, the Commission also plans to increase the civil penalty amounts 
specified in its Enforcement Policy in NUREG-1600, Rev. 1, for 
violations involving lost or improperly disposed of sources or devices. 
This increase will better relate the civil penalty amount to the costs 
avoided by the failure to properly dispose of the source or device. Due 
to the diversity of the types of sources and devices, the Commission is 
considering the establishment of three levels of base civil penalty for 
loss or improper disposal. The higher tiers would be for sources that 
are relatively costly to dispose of.

Discussion

    The Atomic Energy Act of 1954 (AEA), as amended, authorizes the NRC 
to request appropriate information from its licensees concerning 
licensed activities. However, the Commission had not included such an 
explicit provision in the regulations governing 10 CFR 31.5 general 
licensees.
    This final rule adds an explicit requirement to 10 CFR 31.5 that 
requires general licensees who possess certain measuring, gauging, and 
controlling devices to respond in a timely way to written requests from 
the NRC for information concerning products that they have received for 
use under a general license.
    The final rule requires a response to requests within 30 days or 
such other time as specified in the request. For routine requests for 
information, 30 days should be adequate in most instances, and an 
extension can be obtained for good cause. If more complicated requests 
are made or circumstances recognized that may require a longer time, 
the Commission may provide a longer response time. In the unusual 
circumstance of a significant safety concern, the Commission could 
demand information in a shorter time. The NRC will provide a phone 
number in the request for information in case additional guidance is 
necessary.
    The NRC intends to use this provision primarily to institute an 
annual registration program for devices using certain quantities of 
specific radionuclides. The registration program is primarily intended 
to ensure that general licensees are aware of and understand the 
requirements for the possession of devices containing byproduct 
material. The registration process will allow NRC to account for 
devices that have been distributed for use under the general license. 
The NRC believes that, if general licensees are aware of their 
responsibilities, they will comply with the requirements for proper 
handling and disposal of generally licensed devices. This should help 
reduce the potential for incidents that could result in unnecessary 
radiation exposure to the public as well as contamination of property.
    The general licensees covered by the registration program will be 
asked to account for the devices in their possession and to verify, as 
well as certify, information concerning--
    (1) The identification of devices, such as the manufacturer, model, 
and serial numbers;
    (2) The persons knowledgeable of the device and the applicable 
regulations;
    (3) The disposition of the devices; and
    (4) The location of the devices.
    An organization which uses generally licensed devices at numerous 
locations is usually considered a separate general licensee at each 
location (except in the case of different facilities at the same 
complex or campus). In the case of

[[Page 42271]]

portable devices that are routinely used at multiple sites, there is 
one general licensee for each primary place of storage, not for each 
place of use. Thus, an organization may be required to complete more 
than one registration, if it possess devices subject to registration at 
multiple locations.
    While the final rule applies to all 10 CFR 31.5 general licensees 
(about 45,000), the NRC will contact only approximately 5100 general 
licensees, possessing about 20,000 devices, for registration purposes. 
This category of general licensees is based on the criteria recommended 
by the working group for determining which sources should have 
increased oversight. The proposed rule presented an estimate of 6000 
general licensees, based on the estimates made in the working group 
report. However, this had not accounted for the fact that, in the 
interim, Massachusetts had become an Agreement State. Using the same 
criteria, and removing the previously NRC general licensees in 
Massachusetts, results in an estimate of 5100. Other States are 
expected to become Agreement States in the near future which will 
affect the number of general licensees under NRC jurisdiction, but not 
the overall number nationally. The separate, more comprehensive 
proposed rule published July 26, 1999, indicated that Agreement States 
will be required to achieve a compatible level of accountability over 
generally licensed devices. Thus, following State implementation of 
compatible programs in conjunction with that rule, further changes in 
the number of generally licensed devices within NRC jurisdiction should 
not adversely affect accountability.
    Requests for information will be sent to general licensees who are 
expected, based on current NRC records, to possess devices containing 
(as indicated on the label) at least--

370 MBq (10 mCi) of cesium-137;
3.7 MBq (0.1 mCi) of strontium-90;
37 MBq (1 mCi) of cobalt-60; or
37 MBq (1 mCi) of any transuranic (at this time, the only generally 
licensed devices meeting this criterion contain curium-244 and 
americium-241).

    Most of the devices meeting these criteria are used in commercial 
and industrial applications measuring thickness, density, or chemical 
composition in petrochemical and steel manufacturing industries. The 
requests will include the information contained in NRC records 
concerning the possession of these devices. The licensees will be asked 
to verify, correct, and add to that information. The NRC records are 
based on information provided to the NRC by distributors under 10 CFR 
32.52(a) and compatible Agreement State regulations and from general 
licensees as required by 10 CFR 31.5(c) (8) or (9) regarding transfer 
of generally licensed devices. If a general licensee no longer 
possesses devices meeting the criteria, it will be expected to provide 
information about the disposition of the devices previously possessed. 
Errors in current NRC records concerning these general licensees could 
be the result of--
    (1) Errors made in the quarterly reports of manufacturers or 
initial distributors;
    (2) General licensees not reporting transfers; or
    (3) Errors made by NRC or its contractors in recording transfer 
information.
    In addition to the 5100 general licensees identified for 
registration, the NRC may occasionally request information from other 
general licensees on a case-by-case basis as necessary or appropriate. 
For example, this might involve investigating the extent that other 
users have experienced a problem that has been identified with the 
design of a particular device model. However, significant modifications 
to the registration program to include a larger class of licensees 
would be done through rulemaking.
    Although the amendment to the regulations imposes some additional 
costs on licensees, the NRC has estimated these costs to be minimal. 
This cost is the estimated administrative cost expended by general 
licensees to verify the information requested by the NRC regarding 
licensed devices. The NRC believes that the rule's intended effect of 
increased compliance by general licensees with regulatory requirements, 
and resulting NRC and public confidence in the general license program 
potentially afforded by these new requirements, outweigh this nominal 
administrative cost.

Public Comments on the Proposed Rule

    The NRC reviewed the public comments received on the December 2, 
1998, proposed rule. Seven comment letters were received from: the 
State of Illinois (an Agreement State), National Steel Pellet Company, 
Steel Manufacturers Association (SMA), the Commonwealth of 
Massachusetts (an Agreement State), the State of New Jersey (a non-
Agreement State), American Iron and Steel Institute (AISI), and one 
private citizen.
    All commenters supported the proposed rule. One commenter agreed 
with the NRC that the proposed change would increase accountability and 
control over generally licensed radioactive devices. Another commenter 
supported the proposed regulation as a step in the right direction, if 
not completely solving the regulatory problems of the NRC. The steel 
industry supported the proposed rule as a positive, although small, 
step toward minimizing the risk associated with improper disposal of 
spent sources in the scrap supply.
    Agreement was expressed by two commenters that the administrative 
burden on general licensees to provide the minimal information 
requested by the NRC is reasonable, as is the 30-day period in which 
general licensees have to respond, with extensions granted for good 
cause.
    Several commenters voiced agreement with the interim enforcement 
policy. One commenter, the State of New Jersey, believes that it is 
extremely important to remove any incentive for a general licensee to 
attempt to discard its source rather than comply with the reporting 
requirement. The commenter stated that when people get rid of their 
generally licensed devices in a hurry, the State has to go out and find 
them in mountains of trash or scrap metal.
    Two other commenters, the SMA and AISI, stated that they would 
support any enforcement program that deters improper disposal of 
radioactive sources. They also endorse the provision allowing general 
licensees to report and correct violations without incurring penalties. 
These commenters believe that this provision would encourage licensees, 
who are not sure about sources they hold, to remedy the problem rather 
than improperly dispose of the sources in an attempt to avoid high 
penalties.

A. Current NRC General Licensing Process and Cost Shift

    Comment: In general, the three representatives of the steel 
industry expressed similar concerns regarding the current NRC general 
licensing process. One commenter, the SMA, stated that the proposed 
rule did not address the fact that the current regulatory regime has 
shifted the costs of lax accountability and control onto steel makers, 
insurers, and the taxpayers. This commenter stated that general 
licensees do not pay for their licenses nor provide information 
directly to NRC about the sources they hold. Instead, the cost has 
fallen on steel producers to detect the sources, on steel producers and 
taxpayers to arrange for proper disposal, and on steel producers and 
their insurers to pay the cost when a source is inadvertently melted. 
This commenter believed that general

[[Page 42272]]

licensees should be required to shoulder their fair share.
    Similarly, the AISI pointed out that current NRC regulations have 
inadvertently and improperly shifted the costs for accountability and 
control onto hot metal producers, insurers, and taxpayers and that 
steel producers are being forced to pay the cost of detecting orphaned 
sources, to arrange for proper disposal, and to pay for the cleanup 
when a source is inadvertently melted. This commenter also believed 
that general licensees should be required to pay their fair share of 
these costs and stated that improving licensee accountability would 
also reduce the risk of the illegal release of generally licensed 
material into the public scrap supply. In addition, the AISI noted that 
the inadvertent melting of orphaned sources by domestic steel producers 
has resulted in decontamination, disposal, and lost production costs 
ranging between $10 million and $24 million at electric furnace mills 
and that the cost of a similar incident occurring in a major integrated 
steel mill could easily exceed $100 million.
    Response: The Commission recognizes the expense to the steel 
industry when generally licensed devices containing radioactive 
material are not properly disposed of or properly handled. The NRC 
believes that this rulemaking will reduce the probability of lost and 
improperly disposed of sources, and ultimately the number of incidents 
of inadvertent meltings. This would reduce the total expense to the 
steel industry, insurers, and taxpayers resulting from such incidents. 
A separate, more comprehensive rulemaking on this subject (proposed on 
July 26, 1999) is expected to further improve accountability for 
devices and reduce the impact of improperly disposed of sources to the 
steel industry. In addition, that rule would establish a registration 
fee to recover the cost of the NRC enhanced oversight program for those 
general licensees being required to register their devices.

B. Reporting Electronically and Data Verification

    Comment: Two commenters recommended that the NRC provide a means 
for electronically reporting the information requested by the NRC in 
order to save time, mailing expenses, and paper. They also indicated 
that the NRC should ensure that its database has an adequate data 
quality verification system and can easily flag inconsistencies.
    One commenter suggested that the electronic filing could be 
accomplished through a secure page on the NRC Internet Web Site and 
that the NRC could use the employer's tax identification number and a 
password to secure the information. This commenter also recommended 
that the NRC database include a data quality verification system to 
quickly identify and immediately notify licensees of any reporting 
inconsistencies and that employers could also be required to annually 
verify the accuracy of the inventory.
    Response: The submission of electronic applications and reports is 
a generic issue that impacts more than the general license registration 
program. The NRC has evaluated the issue of permitting licensees to 
file applications and reports electronically and plans to publish an 
amendment to the regulations to allow such submissions. The NRC expects 
to publish the amendment next year. At that time, the NRC will evaluate 
how this change will impact implementation of the registration program 
and future enhancements to the design of the automated system. However, 
the NRC currently expects that the initial registration program would 
require submission of hard copies of the registration forms.
    The NRC is in the process of upgrading its information technology 
systems to facilitate processing of annual registrations. The upgrades 
will include adequate data verification for distributor, general 
licensee, and registration information and will include automated 
readers for processing the large volume of registration forms. The 
automated readers will identify changes and inconsistencies with the 
database, convert changes to electronic form, and incorporate the new 
data.

C. Control and Accountability

    Comment: One commenter believed that a great deal of improvement is 
needed in the regulations governing licensed radioactive devices 
concerning their location and whether they are being disposed of 
properly. This commenter felt that a license should not be given out to 
persons to own as many devices as they please; instead a license should 
be given out per device, thereby limiting the number of devices 
available and making known the number of devices in use. This commenter 
felt that radioactive material presents an extreme threat to health and 
safety even if disposed of properly.
    Response: The Commission does not believe it is necessary, 
appropriate, or practical to limit the number of devices going out to 
general licensees to one per licensee. Tracking the number of devices 
in use and who has them is achievable without such a restriction. 
Generally licensed devices are designed to be inherently safe and do 
not present nearly as great a risk to health and safety as the 
commenter suggests. Given the nature of the general license, 
restrictions on numbers of devices that can be possessed would be 
difficult to enforce and would likely lead to difficulties in getting 
accurate information on devices possessed.
    Comment: Another commenter recommended that the NRC not target 
businesses with specific licenses, pointing out that they are required 
to--
    (1) Have a Radiation Safety Officer;
    (2) Actively perform testing and inspections; and
    (3) Maintain written documentation.
    Therefore, specific licensees are almost always aware of the 
byproduct material regulations applicable to byproduct material managed 
under a general license as well and are more likely to adequately 
account for and handle devices containing byproduct material in 
accordance with the regulatory requirements. The commenter recommended 
that the NRC instead target general licensees that do not currently 
maintain byproduct material under a specific NRC license because these 
general licensees are more likely to be unaware of the appropriate 
regulations and are more likely to inappropriately account for and 
handle devices containing byproduct material.
    Response: Specific licensees who also have generally licensed 
devices are subject to any regulations applicable to the general 
license. Therefore, these specific licensees will be subject to 
registration. Given the approach of this first rule, it would be 
possible for NRC to simply not make this request for information from 
those who also hold specific licenses. However, this would require 
additional effort to cross reference data on specific licensees with 
that on general licensees. Specific licensees, while generally more 
aware of applicable regulations, do have problems with incomplete 
accountability for devices. The potential improvement in accountability 
should justify the limited administrative effort of providing 
registration information even in the case of those holding specific 
licenses.
    If the additional rulemaking concerning registration is made final, 
specific licensees holding generally licensed devices subject to 
registration may wish to avoid the additional fee. If so, they would 
have the option of amending their specific license, if necessary, to 
include the devices, and thereby remove the devices from the

[[Page 42273]]

general license status. In this case, labels may have to be changed to 
be consistent with the device's regulatory status.
    Comment: The State of Illinois indicated that a group of general 
licensees in Illinois possesses devices containing curium-244 in 
quantities that would require registration under the proposed rule. 
This commenter recommended that the NRC contact licensees possessing 
not only americium-241 but also curium-244, and noted that the 
statement in the December 2, 1998, proposed rule (63 FR 66493) that 
americium-241 is the only transuranic radionuclide found in generally 
licensed devices in quantities exceeding 37 megabecquerels (1 
millicurie), is in error.
    Response: The Commission agrees. The omission in that statement, of 
curium-244 as a transuranic element used in generally licensed devices 
meeting the criteria for registration, was an oversight. Devices 
containing curium-244 with quantities meeting the criterion for 
transuranics will be included in the registration requirement.
    Comment: Several commenters stated that the NRC should give serious 
consideration to the NRC-Agreement State Working Group recommendations 
as contained in NUREG-1551, ``Final Report of the NRC-Agreement State 
Working Group to Evaluate Control and Accountability of Licensed 
Devices.'' Specifically, one commenter stated that there should be a 
Responsible Individual (RI) and a Backup Responsible Individual (BRI) 
for each general license. This commenter stated that, unlike a specific 
license where there are a Radiation Safety Officer and Authorized 
Users, there may be only one person (RI) who has a real understanding 
that his or her company possesses a generally licensed device that 
contains a radioactive source. When that RI dies, retires, resigns, or 
is laid off, there may be no one at the facility with any understanding 
or appreciation of the significance of the generally licensed device. 
The commenter stated that the addition of one extra name and phone 
number to the records should not be too burdensome on the licensee and 
may help avoid the burden of responding to a radiation incident 
involving the device.
    Two other commenters recommended that the NRC consider the Working 
Group's recommended comprehensive measures, including requirements for 
the NRC to maintain inventory records, to compare and reconcile related 
discrepancies, and to mandate reporting the bankruptcy of a licensee to 
the NRC. The commenters also recommended State/NRC site inspections and 
inventories at regular intervals. These commenters felt that serious 
consideration should be given to each of these measures in order to 
prevent the continued loss of licensed sources into the scrap stream.
    One of these commenters also urged the NRC to move forward with the 
planned additional regulations amending or establishing requirements 
for registration fees, labeling, and compatibility with Agreement State 
requirements. The commenter stated that the limited registration 
program would have minimal impact on the radioactive scrap problem if 
it is the only amendment the NRC proposes.
    Response: The more comprehensive measures recommended by the NRC-
Agreement State Working Group are being considered in the separate, 
more comprehensive rule proposed on July 26, 1999. Comments on these 
issues will be considered as part of that rulemaking process.

D. Registration Program

    Comment: One commenter noted that the language of the proposal did 
not call for a periodic registration program requiring reporting at 
least annually. Rather, the proposed amendment would merely restate 
NRC's authority to collect information from licensees. The commenter 
pointed out that the NRC already has this authority under 42 U.S.C. 
2095 and in its own regulations at 10 CFR 30.34. This commenter urged 
the NRC to explicitly call for a periodic registration program in the 
amended regulation stating that this would remind general licensees 
that they have licensed radioactive sources and that there are 
responsibilities attached to their licenses. It would also indicate 
that the Government has knowledge of their sources and the authority to 
enforce prohibitions on improper disposal.
    Response: The NRC has proposed explicit provisions for an annual 
registration requirement in the separate, more comprehensive rule on 
this subject.
    Comment: A commenter suggested that the NRC reconsider one of the 
provisions in a proposed rule published February 5, 1974 (39 FR 4583), 
that would have required registration of the generally licensed devices 
before customers are allowed to receive them. This commenter stated 
that this would ensure and document that general licensees have 
received copies of the regulations and that they are aware of their 
rights and responsibilities.
    Response: The Commission does not believe preregistration is 
necessary to ensure and document that general licensees have received 
copies of the regulations and that they are aware of their rights and 
responsibilities. However, the Commission has proposed amendments to 
address the need for customers to receive additional information prior 
to purchases of generally licensed devices in the separate, more 
comprehensive rule.
    Comment: Another commenter strongly encouraged the NRC to adopt a 
mandatory registration program for all sources, not merely those that 
pose the greatest risk to steel mills.
    Response: The Commission has decided to use the criteria developed 
by the NRC/Agreement State Working Group to determine which sources 
should be subject to the registration program. These criteria were 
based on considerations of relative risk and were limited to 
radionuclides currently in use in devices considered to present a 
higher risk of potential exposure, as well as potential for 
contamination of property.

E. Fee-Based System

    Comment: One commenter believed that a fee-based system for all 
general licensees would ensure that the NRC recovers the minimal cost 
to initiate and maintain the reporting program. The commenter stated 
that such a registration program would enable the NRC to account for 
all sources that have been distributed. The commenter further suggested 
that the program could be designed to allow steel companies and the 
general public to trace the origins of an improperly disposed of 
source. This would help steel companies in determining liability for 
the multimillion-dollar clean-up costs that the steel companies and 
their insurers incur when sources are inadvertently melted. It would 
also provide Federal and State nuclear regulators that handle orphan 
sources a means to obtain reimbursement resulting in an additional 
deterrent against improper source disposition.
    Another commenter was concerned that, even though a fee-based 
system for all general licensees would permit the NRC to recover the 
anticipated cost of initiating and maintaining the reporting program, a 
fee schedule could slow or prevent implementation of the entire 
proposal. If this is correct, the commenter recommended that the NRC 
retain the proposal as published.
    Response: The Commission is not addressing comments on its proposed 
fee-based system as part of this rulemaking process. The separate, more

[[Page 42274]]

comprehensive rule addresses fees for registration and the comments 
will be considered in connection with that rulemaking.

F. Registration Information Available on the Internet

    Comment: One commenter was opposed to making the registration 
information available on the Internet because such posting would 
unnecessarily cause public concern over the presence and use of low 
level devices. The commenter believes that this information should be 
available only through the Freedom of Information Act request process.
    Response: Some of the information submitted in distributor 
quarterly reports and entered into the general license tracking system 
that is to be used for handling registration information would be 
considered proprietary. This database will be designed with security 
features in order to protect proprietary information. It will not be 
available on the Internet. The NRC would post information on its 
website concerning lost or unaccounted for devices.

G. Civil Penalty Amounts

    Comment: One commenter agreed with the NRC's intent to increase the 
civil penalty amounts for violations involving lost or improperly 
disposed of sources or devices. The commenter stated that the penalties 
must be significantly higher than the costs avoided by the failure to 
properly dispose of the source or device.
    A second commenter supported fining general licensees who violate 
their general licenses by using a schedule that is proportionate to the 
damage actually caused by the lost source. The commenter used the 
example of the cost for cleaning a steel mill contaminated by melting 
such a source. This commenter believed that because the NRC's proposed 
penalty is not much higher than the current fine of $2500 per loss that 
has been assessed to licensees, it would not significantly deter 
illegal behavior. The commenter believes that increasing the current 
relatively minimal penalty levels to amounts that reflect the real 
world damage caused by loss of a licensed source will provide general 
licensees with a substantive economic incentive to dispose of their 
sources legally.
    Response: As discussed in the July 26, 1999 (64 FR 40295) proposed 
rule, the Commission is considering raising civil penalties for 
violations involving lost or improperly disposed of sources or devices 
and may use a tiered approach with higher than usual civil penalties 
for sources that are relatively costly to dispose of. This is to ensure 
that such civil penalties better relate to the costs avoided by the 
failure to properly dispose of the source or device. The cost of 
cleaning a contaminated steel mill would not be an appropriate basis 
for setting fees.
    No comments were made concerning the specific wording of the 
proposed amendment. No change to the rule has been made as a result of 
these comments.

Agreement State Compatibility

    Under the ``Policy Statement on Adequacy and Compatibility of 
Agreement State Programs'' approved by the Commission on June 30, 1997 
(62 FR 46517), this final rule is classified as Compatibility Category 
D. Category D means the provisions are not required for purposes of 
compatibility; however, if adopted by the State, the provisions should 
not create any conflicts, duplications, or gaps in the regulation of 
AEA material. Ultimately, an enhanced oversight program is expected to 
include provisions that will require a higher degree of compatibility. 
This is being considered in the separate, more comprehensive rulemaking 
that would add more explicit requirements for the registration program 
and additional provisions concerning accountability of generally 
licensed devices.

Voluntary Consensus Standards

    The National Technology Transfer and Advancement Act of 1995, Pub. 
L. 104-113, requires that agencies use technical standards that are 
developed or adopted by voluntary consensus standards bodies unless the 
use of such a standard is inconsistent with applicable law or otherwise 
impractical. In this final rule, the NRC is amending its regulations to 
require that those who possess certain industrial devices containing 
byproduct material provide requested information. The amendments are 
administrative in nature and require certain types of specific entities 
to provide information concerning specific devices in their possession. 
Therefore, this action does not constitute the establishment of a 
standard that establishes generally applicable requirements.

Environmental Impact: Categorical Exclusion

    The NRC has determined that this final rule is the type of action 
described in the categorical exclusion in 10 CFR 51.22(c)(3)(iii). 
Therefore, neither an environmental impact statement nor an 
environmental assessment has been prepared for this regulation.

Paperwork Reduction Act Statement

    This final rule amends information collection requirements that are 
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.). The information collection requirements in this rule have been 
approved by the Office of Management and Budget, approval number 3150-
0016.
    The public reporting burden for this information collection is 
estimated to average 20 minutes per response, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
information collection. Send comments on any aspect of this information 
collection, including suggestion for reducing the burden, to the 
Records Management Branch (T-6 E6), U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, or by Internet electronic mail at 
[email protected]; and to the Desk Officer, Office of Information and 
Regulatory Affairs, NEOB-10202, (3150-0016), Office of Management and 
Budget, Washington, DC 20503.

Public Protection Notification

    If a means used to impose an information collection does not 
display a currently valid OMB control number, the NRC may not conduct 
or sponsor, and a person is not required to respond to, the information 
collection.

Regulatory Analysis

    The NRC has prepared a regulatory analysis for this regulation. The 
analysis examines the cost and benefits of the alternatives considered 
by the NRC. The regulatory analysis is available for inspection in the 
NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, 
DC. Single copies of the analysis may be obtained by calling Jayne 
McCausland, U.S. Nuclear Regulatory Commission, Office of Nuclear 
Material Safety and Safeguards, Washington, DC, 20555-0001; telephone 
(301) 415-6219; or e-mail at JMM[email protected].

Regulatory Flexibility Certification

    As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), 
the Commission certifies that this final rule does not have a 
significant economic impact on a substantial number of small entities. 
This rule requires general licensees who have received specific devices 
to respond to requests for information from NRC. The final rule applies 
to the approximately 45,000 persons using products under an NRC general 
license, many of whom may be classified as small entities. However, the

[[Page 42275]]

NRC intends to request registration information from only approximately 
5100 of these general licensees. Registration information to be 
obtained will include identification of the devices, accountability for 
the devices, the persons knowledgeable of the device and the applicable 
regulations, and the disposition of the devices. The NRC believes that 
the economic impact that any general licensee incurs as a result of 
supplying this information constitutes a negligible increase in 
administrative burden. It is estimated that there are approximately 
20,000 devices in the possession of the Commission's general licensees 
which will come under the registration requirement. The average cost to 
the general licensee per device per year is about $4.00. Therefore, the 
action will not have a significant economic impact on small entities. 
The final rule is intended to ensure that general licensees understand 
and comply with regulatory responsibilities regarding the generally 
licensed radioactive devices in their possession.

Backfit Analysis

    The NRC has determined that the backfit rule, 10 CFR 50.109, does 
not apply to this rule, because these amendments do not involve any 
provisions that impose backfits as defined in 10 CFR 50.109(a)(1) and, 
therefore, a backfit analysis is not required.

Small Business Regulatory Enforcement Fairness Act

    In accordance with the Small Business Regulatory Enforcement 
Fairness Act of 1996, the NRC has determined that this action is not a 
major rule and has verified this determination with the Office of 
Information and Regulatory Affairs, Office of Management and Budget.

List of Subjects in 10 CFR Part 31

    Byproduct material, Criminal penalties, Labeling, Nuclear 
materials, Packaging and containers, Radiation protection, Reporting 
and recordkeeping requirements, Scientific equipment.
    For the reasons set out above and under the authority of the Atomic 
Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, 
as amended, and 5 U.S.C. 552 and 553, the NRC is adopting the following 
amendments to 10 CFR Part 31.

PART 31--GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL

    1. The authority citation for Part 31 continues to read as follows:

    Authority: Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as 
amended (42 U.S.C. 2111, 2201, 2233); secs. 201, as amended, 202, 88 
Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842).

    Section 31.6 also issued under sec. 274, 73 Stat. 688 (42 U.S.C. 
2021).
    2. Section 31.5 is amended by adding paragraph (c)(11) to read as 
follows:


Sec. 31.5  Certain measuring, gauging, or controlling devices.\2\

* * * * *
    (c) * * *
    (11) Shall respond to written requests from the Nuclear Regulatory 
Commission to provide information relating to the general license 
within 30 calendar days of the date of the request, or other time 
specified in the request. If the general licensee cannot provide the 
requested information within the allotted time, it shall, within that 
same time period, request a longer period to supply the information by 
submitting a letter to the Director, Office of Nuclear Material Safety 
and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001 and provide written justification as to why it cannot 
comply.
---------------------------------------------------------------------------

    \2\ Persons possessing byproduct material in devices under a 
general license in 10 CFR 31.5 before January 15, 1975, may continue 
to possess, use, or transfer that material in accordance with the 
labeling requirements of 10 CFR 31.5 in effect on January 14, 1975.
---------------------------------------------------------------------------

* * * * *
    Dated at Rockville, Maryland, this 1st day of July, 1999.

    For the Nuclear Regulatory Commission.
William D. Travers,
Executive Director for Operations.
[FR Doc. 99-19984 Filed 8-3-99; 8:45 am]
BILLING CODE 7590-01-P